Episcleral Brachytherapy for the Treatment of Wet AMD

NCT02988895 | Unknown FDA Device

• 1 other identifier: SMD-201601
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

Brief Summary

This is a prospective, multi-site, safety and feasibility study of the SalutarisMD SMD-DA system for retrobulbar minimally invasive episcleral brachytherapy device in patients receiving and not responding to anti-VEGF therapy for nAMD. The trial will be open label and non-randomized. The study intervention is a one-time intervention and requires no alteration to the standard of care during the follow-up period.

Conditions

Macular Degeneration, Choroidal Neovascularization

Keywords

Brachytherapy; Wet AMD

Outcome Measures

Primary Outcomes (3)

• Safety of the study intervention

  Adverse event assessment

  26 weeks

• Tolerability of the study intervention

  Subject pain score during procedure

  During procedure

• Feasibility of the study intervention

  Investigator ability to place the device and deliver a therapeutic dose

  1 day

Study Arms (1)

episcleral brachytherapy

EXPERIMENTAL

single fraction of 24 Gy Strontium90 episcleral brachytherapy

Radiation: episcleral brachytherapy

Interventions

episcleral brachytherapy RADIATION

The study intervention is an outpatient, ambulatory procedure performed under local anesthesia with anesthesia assist.

Also known as: Strontium 90

episcleral brachytherapy

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of active CNV or PCV due to nAMD
• Poor or non-responsive to FDA approved intravitreal anti-VEGF therapy for nAMD
• BCVA 20/63 or worse Snellen equivalent in the study eye
• Ability to understand nature/purpose of trial and to provide informed consent
• Ability to undergo diagnostic tests and surgical interventions
• Ability to follow instructions and complete the trial including all scheduled visits and follow-up

You may not qualify if:

• Neovascularization other than due to AMD
• Sub-foveal lesion hemorrhage obscuring \>50% of lesion
• Targeted neovascular lesion with greatest linear dimension \>3750 microns or \<1000 microns as determined by angiography
• Presence of subretinal fibrosis, including disciform scar, or retinal pigment epithelial (RPE) atrophy that is extensive or foveal threatening in the study eye
• An existing retinal pigment epithelial (RPE) tear
• Previous treatment (excluding vitamins) for nAMD in the study eye other than anti-VEGF therapy in the last 6 months
• A change in anti-VEGF agent in the previous two administrations
• Anticipate a change to the anti-VEGF agent during the conduct of the study
• Other clinically significant ocular co-morbidity including, but not limited to, glaucoma, optic neuropathy of any cause, maculopathy / retinopathy of any cause other than nAMD, scleritis, enophthalmos, microphthalmia, or other co-morbidities that in the investigator's opinion could require medical or surgical intervention to prevent or treat visual loss or media opacity that might result from that condition (i.e. severe cataracts).
• Previous intraocular surgery in study eye other than for uncomplicated phacoemulsification cataract extraction
• High myopia indicated by a history of refractive error of - 6D or greater (spherical equivalent), demonstrated myopic degeneration, or axial length of \>26.5mm.
• Subjects with orbital structural abnormalities, such as small (axial length \<21 mm), deep set globes or other globe dystopias that, in the investigator's clinical judgment, would require a change in the angle of insertion or increase the risk of structural damage from retrobulbar anesthesia, sub-Tenon's anesthesia, or retrobulbar device positioning.
• Media opacity sufficient to preclude adequate fundoscopy, OCT, or angiography
• Uncontrolled systemic diseases (e.g. controlled hypertension is acceptable)
• Type I or type II diabetes mellitus

Sponsors & Collaborators

• Salutaris Medical Devices, Inc.: lead

Study Sites (2)

Retina Consultants of Hawaii

‘Aiea, Hawaii, 96701, United States

Location

University Retina

Oak Forest, Illinois, 60452, United States

Location

MeSH Terms

Conditions

Choroidal Neovascularization

Interventions

Strontium-90

Condition Hierarchy (Ancestors)

Choroid Diseases; Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: December 9, 2016
• Study Start: August 1, 2017
• Primary Completion: May 26, 2023
• Study Completion: May 1, 2025
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)